Otsuka settles Abilify allegations for $4 million

TOKYO Otsuka Pharmaceuticals has agreed to pay $4 million to resolve allegations that it marketed its schizophrenia drug Abilify for off-label uses with Bristol-Myers Squibb, according to published reports.

Squibb settled its issue with Abilify back in September by agreeing to pay $515 million to settle allegations that it overcharged the government for drugs and promoted medicine like Abilify for unapproved uses.

The accusations came from the Justice Department, which stated that the companies of promoting the drug for use in children, and as a remedy for dementia, without FDA approval. Now, the drug is required to carry a black-box warning for use in dementia-related psychosis.

Otsuka will pay the government about $2.3 million and the remainder to states’ Medicaid programs, the company said in a statement. It agreed to a corporate integrity agreement, without specifying the length of the compliance and monitoring pledged. The agreement requires the company to maintain compliance programs to monitor business practices.

Over 12.5 million prescriptions have been written as of June 2007 for Abilify, according to IMS.

Sugar may be helpful for those with diabetes and obesity

BALTIMORE Researchers have found a new treatment that may be helpful in aiding those with diabetes and obesity, and it is most unusually a sugar.

The sugar is known as tagatose, which, according to published reports, is used in Europe to sweeten candy or orange juice. It is a naturally occurring version of fructose and is derived from the dairy byproduct whey. Tagatose has been shown to stop blood sugar spiking and is currently undergoing a one-year clinical trial to see if is, in fact, helpful in managing diabetes and weight-loss.

According to the American Diabetes Association, about 20.8 million people are diabetic and 9 out of 10 diabetics with Type 2 are overweight. Many researchers, such as Phillip Levin, an endocrinologist and director of diabetes center at Mercy, hope that tagatose can become a diet drug for patients experiencing obesity, one of the leading causes of diabetes. According to Levin, “Tagatose could be another tool for damage control. A lot of dealing with Type 2 diabetes is damage control.”

Other studies have shown that tagatose, if ingested before meals, would stop the rise in blood sugar, because it is absorbed poorly and therefore affects the way the sugar is stored. According to published reports, tagatose is said to be possibly the only diabetes drug that could raise good cholesterol and act as a cell-protecting antioxidant.

FDA to take a closer look at Singulair

WASHINGTON The Food and Drug Administration has warned health care professionals that it is investigating possible side effects in the asthma drug Singulair.

Possible side effects of the drug, a Merck product, include behavior/mood changes, suicidality and suicide.

The agency will need up to nine months to complete ongoing evaluations about the safety of the drug.

“Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information,” the FDA said. “Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality and changes in behavior and mood.”

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Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
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Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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